Strafford will be offering a webinar/teleconference entitled "Biosimilars: Draft FDA Guidance and Emerging Legal Challenges -- Navigating FDA's Approval Pathway, Patent Issues, and the Complexities of Exclusivity" on October 23, 2012 from 1:00 - 2:30 pm (EDT). Patent Docs author Dr. Kevin Noonan of McDonnell, Boehnen, Hulbert & Berghoff LLP and Howard W. Levine of Finnegan Henderson Farabow Garrett & Dunner will provide IP attorneys with a review of the FDA draft guidance and the complex standards of the FDA's Biosimilar Approval Pathway and will address patent and exclusivity concerns around the development and marketing of biosimilars.. The webinar will review the following questions:
How will the draft guidance impact protection for biosimilars?
• What are the FDA's definitions for "highly similar" and "interchangeability"?
• What are the market protection issues raised by patent exchange procedures for biopharmaceuticals?
• What is the criteria for the 12-year exclusivity period?
The registration fee for the webinar is $297 ($362 for registration and CLE processing). Those registering by September 28, 2012 will receive a $50 discount. Those interested in registering for the webinar, can do so here.